Potency of Topical Corticosteroids in Combination Preparations

• ClinicalTrials.gov Identifier: NCT03606954
• Recruitment Status: Unknown
• First Posted: July 31, 2018
• Last Update Posted: July 31, 2018
• Sponsor: Ben-Gurion University of the Negev
• Collaborator: Soroka University Medical Center
• Information provided by (Responsible Party): Alex Zvulunov, Ben-Gurion University of the Negev

Study Description

Brief Summary:

Several combination topical drugs are available on the market. The potency of corticosteroids depends on a particular molecular structure and the skin penetration properties. Besides molecular structure, a penetration of a corticosteroid molecule correlates with physical properties of the vehicle which depend on physical properties of the vehicle constituents.

Vasoconstriction assay is considered as the gold standard for testing potency of topical corticosteroids.

Condition or disease	Intervention/treatment	Phase
Skin Toxicity	Combination Product: Combination topical corticosteroid	Phase 4

Detailed Description:

Primary outcome: Change in Vasoconstriction index following application of topical corticosteroids that are incorporated with or without an antibiotic and/or antifungal drugs in healthy volunteers.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: double-blind controlled comparative study
• Primary Purpose: Other
• Official Title: Evaluation of Topical Corticosteroids Potency in Combination Preparations in Healthy Volunteers
• Estimated Study Start Date: November 2018
• Estimated Primary Completion Date: March 2019
• Estimated Study Completion Date: April 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Combination topical corticosteroid; The combination topical corticosteroid will be applied to specific and marked sites on the forearms (on the flexor side of the forearm- 5*5 cm with a distance of 3 cm) - two sites on both forearms of every subject (4 sites in total). The nature of this application method will enable the measurement of the level of potency of each drug, in a manner that is comparative, neutralizing thus the influence of inter-subject variability. The drugs will be topically applied (50 microliter on each site) for 16 hours, utilizing an occlusive dressing bandage such as Tegaderm. The vasoconstriction test will be preformed both before and after drug application. The vasoconstriction in each subject will be graded on the Olsen scale	Combination Product: Combination topical corticosteroid; Comparison of a vasoconstriction index between the 2 study arms
Active Comparator: Non-combination topical corticosteroid; The non-combination topical corticosteroid will be applied to specific and marked sites on the forearms (on the flexor side of the forearm- 5*5 cm with a distance of 3 cm) - two sites on both forearms of every subject (4 sites in total). The nature of this application method will enable the measurement of the level of potency of each drug, in a manner that is comparative, neutralizing thus the influence of inter-subject variability. The drugs will be topically applied (50 microliter on each site) for 16 hours, utilizing an occlusive dressing bandage such as Tegaderm. The vasoconstriction test will be preformed both before and after drug application. The vasoconstriction in each subject will be graded on the Olsen scale	Combination Product: Combination topical corticosteroid; Comparison of a vasoconstriction index between the 2 study arms

Outcome Measures

Primary Outcome Measures :

1. Vasoconstriction Index (VI) measured by Skin Color Reflectometry [ Time Frame: 24 hours ]
   VI change following application topical corticosteroids that are incorporated with an antibiotic and/or antifungal drugs.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• No prior history of internal diseases that required vaccine-suppressing treatments
• Absence of an active skin disease.

Exclusion Criteria:

• Treatment with topical corticosteroids in the 4 weeks prior to the study
• Immune-suppressive treatment in the 4 weeks prior to the study
• Pregnancy or breast feeding

Contacts and Locations

Contacts

Contact: Raed Khoury, MD; 0507905159; raedkhoury1@hotmail.com

Contact: Alex Zvulunov, MD; azvulun@bgu.ac.il

Sponsors and Collaborators

Ben-Gurion University of the Negev

Soroka University Medical Center

Investigators

• Principal Investigator: Raed Khoury, MD; Soroka University Medical Center & Ben Gurion University

More Information

• Responsible Party: Alex Zvulunov, Head, Department of Dermatology, Ben-Gurion University of the Negev
• ClinicalTrials.gov Identifier: NCT03606954
• Other Study ID Numbers: 0316-17-SOR
• First Posted: July 31, 2018
• Last Update Posted: July 31, 2018
• Last Verified: July 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No